CN105555231B

CN105555231B - External membrane of heart anchor and method

Info

Publication number: CN105555231B
Application number: CN201480050061.7A
Authority: CN
Inventors: R·维德伦德; M·克里斯蒂安松; C·埃克瓦尔
Original assignee: Individual
Current assignee: Individual
Priority date: 2013-08-01
Filing date: 2014-07-31
Publication date: 2018-02-09
Anticipated expiration: 2034-07-31
Also published as: CA2919379A1; EP3027144A1; US11612480B2; US20160143736A1; US20230149161A1; EP3027144B1; JP2016527033A; AU2014296087B2; US10610354B2; US20200179112A1; CA2919379C; AU2014296087A1; CN105555231A; WO2015017689A1; JP6465883B2

Abstract

This document describes the apparatus and method for anchoring heart valve prosthesis.In certain embodiments, device includes tether attachment members, it includes at least one of base component (240) for limiting tether path (235), and the part that can be received from the tether of artificial heart valve extension via tether path passes therethrough.Base component defines the stop pin passage (234) intersected with tether path.Stop pin (226) can be arranged in stop pin passage and can move between the first position and the second position, in first position, stop pin opens certain distance with tether channel spacing, in the second place, stop pin intersects with tether path and can engage a part for the tether being arranged therein, so as to which tether is fixed into tether attachment members.

Description

External membrane of heart anchor and method

The intersecting reference of related application

This application claims the Application No. 61/861,356 submitted for 1st in August in 2013 and entitled " outside the pocket heart The U.S. Provisional Patent Application of film cushion device (Pursestring Epicardial Pad Device) " and at 2013 10 The moon Application No. 61/895,975 submitted for 25th and entitled " improved external membrane of heart cushion device (Improved Epicardial Pad Device) " U.S. Provisional Patent Application priority and rights and interests, by being cited in full text its disclosure Content is incorporated herein.The application is also the Application No. 14/224,764 and entitled " lotus submitted on March 25th, 2014 Continue Shen in the part of the U.S. Patent application of packet outer membrane cushion device (Pursestring Epicardial Pad Device) " Please, the U.S. Patent application requires the Application No. 61/861,356 submitted for 1st in August in 2013 and entitled " pocket The priority of the U.S. Provisional Patent Application of external membrane of heart cushion device (Pursestring Epicardial Pad Device) " and Rights and interests, by being cited in full text, the disclosure of which is incorporated herein.

Technical field

Embodiment described herein the dress being related to for anchoring medical treatment device such as artificial heart valve Replacement Part Put and method.

Background technology

Some known devices for anchoring medical treatment device such as artificial heart valve (for example, bicuspid valve) can include will Bodily tissue is fixed to from one or more tether of medical treatment device extension.For example, one or more tether can be from the artificial heart Dirty valve extends through the opening in the ventricle wall of heart.Some known methods of anchoring or fixed tether can be including the use of Staple or other fasteners are to engage or be pierced into the tissue near site of puncture.Such device may have relatively Big profile and it is difficult to easily be delivered to desired anchoring position via skin.Known to some of fixed artificial heart valve Method can include suture and extend to the tether of bodily tissue from valve or tie the end of suture.Such device and side Method is likely difficult to be manipulated to fixes one or more tether with desired tension force.

In addition, when directly forming opening in the ventricle wall of heart or the apex of the heart, such as percutaneous conveying and arrangement people When making valve, in addition to artificial valve is secured in place, seal the effect of site of puncture for the life of patient and Say it is most important, reason be because cardiac puncture and caused by haemodynamics loss can cause shock and dead within a few minutes Die.In addition, the outward pressure born when site of puncture is in cardiac muscle itself by site of puncture is located at far above site of puncture The situation in heart distal side.Therefore, for fixing artificial heart valve and being worn for engaging and closing tissue such as closed-heart The improvement apparatus and method at thorn position are identified as that various problems well known in the prior art can be efficiently solved.

The content of the invention

This document describes the apparatus and method for anchoring artificial heart valve.In certain embodiments, a kind of device bag Tether attachment members are included, the tether attachment members include base component, and the base component limits at least the one of tether path Part, the part that can be received from the tether of artificial heart valve extension via the tether path pass therethrough.Base portion structure Part defines stop pin passage, and the stop pin passage intersects with tether path.Stop pin can be arranged in stop pin passage And it can move between the first position and the second position, in the first position, stop pin opens one with tether channel spacing Set a distance, in the second place, stop pin intersects with tether path and can engage one of the tether being arranged therein Point, so as to which tether is fixed into tether attachment members.

Brief description of the drawings

Fig. 1 is a part for the heart of the artificial mitral valves with implantation therein and anchors bicuspid valve outside the heart in place The sectional view of film anchor.

Fig. 2 is the schematic diagram according to the external membrane of heart anchor of an embodiment.

Fig. 3 is the side view according to the external membrane of heart anchor of an embodiment.

Fig. 4 is the decomposition side view one of Fig. 3 external membrane of heart anchor

Fig. 5 is the side view of Fig. 3 external membrane of heart anchor, and it is shown as being arranged to the epicardial surface in ventricle wall In it is spaced a distance with site of puncture, and show the external membrane of heart anchor in uncompressed state or construction Sleeve gasket；

Fig. 6 is Fig. 5 external membrane of heart anchor and the side view of ventricle wall, shows that anchor is compressed against puncture portion On position and ventricle wall and sleeve gasket is in state or the construction of compression；

Fig. 7 is the decomposition side view according to the external membrane of heart anchor of another embodiment；

Fig. 8 is the decomposition side view according to the external membrane of heart anchor of another embodiment；

Fig. 9 is according to the top view of the flexible pad of an embodiment, and the flexible pad can be included in external membrane of heart anchoring dress In putting；

Figure 10 is Fig. 9 flexible pad and is arranged to the perspective view of a part for the tether extended there through；

Figure 11 is the perspective view of the stop pin and tether attachment members according to an embodiment；

Figure 12 is the face upwarding view of Figure 11 tether attachment members；

Figure 13 is the birds-eye perspective for the tether attachment members that can be used according to an embodiment in anchor, its In, lever arm is shown at first position；

Figure 14 is the cross-sectional perspective view of Figure 13 tether attachment members, wherein, lever arm is shown at first position；

Figure 15 is the side cross-sectional view of Figure 13 tether attachment members, wherein, lever arm is shown at first position And a part for tether extends through the device；

Figure 16 is the side cross-sectional view of Figure 13 tether attachment members, wherein, lever arm is shown at the second place And a part for tether extends through the device；

Figure 17 be according to the cross-sectional perspective view of the tether attachment members of an embodiment, wherein, the motion arm quilt of anchor The part for being illustrated at first position and tether extends through the device；

Figure 18 is the side cross-sectional view of the tether attachment members shown in Figure 17, wherein, motion arm is in first position and is A part for rope extends through the device；

Figure 19 is the perspective view of Figure 17 tether attachment members, wherein, conveying device is connected to the tether attachment members；

Figure 20 be Figure 19 tether attachment members and conveying device a part zoomed-in view；

Figure 21 is the birds-eye perspective of Figure 17 tether attachment members, wherein, motion arm is shown at the second place；

Figure 22 is the birds-eye perspective according to the external membrane of heart anchor of another embodiment；

Figure 23 is the top view of Figure 22 external membrane of heart anchor；

Figure 24 is the decomposition view of Figure 22 external membrane of heart anchor；

Figure 25 is the cross-sectional perspective view of Figure 22 external membrane of heart anchor, wherein, the stop pin of the device is shown as locating In first position；

Figure 26 is the side cross-sectional view of Figure 20 external membrane of heart anchor, wherein, the stop pin of the device is shown as locating In first position；

Figure 27 is the sectional top view of Figure 22 external membrane of heart anchor, wherein, stop pin is shown at second Put；

Figure 28 and 29 is the birds-eye perspective and face upwarding view of the bushing of Figure 22 external membrane of heart anchor respectively；

Figure 30 is the top view of the amplification of a part for Figure 22 pericardium cushion device；

Figure 31 is the perspective view of Figure 22 external membrane of heart anchor, wherein, conveying device is connected to the external membrane of heart anchoring Device.

Embodiment

Apparatus and method described herein for example can be used in fixed and anchor artificial heart valve for example artificial mitral valves. Apparatus and method described herein can also be used to close at passing through of being formed during the operation for performing implantation artificial heart valve The opening of heart.Apparatus and method described herein can also be used to anchor other medical treatment devices and/or close at diagnosis or The perforation formed during person's treatment procedure in other body lumens or opening.

In certain embodiments, a kind of device includes tether attachment members, and the tether consolidation component includes base component, The base component defines at least a portion of tether path, can be received from artificial heart valve via the tether path A part for the tether of extension passes therethrough.Base component defines the stop pin passage intersected with tether path.Stop pin energy Enough it is arranged in stop pin passage and can moves between the first position and the second position, in the first position, locking Pin opens certain distance with tether channel spacing, and in the second place, stop pin intersects with tether path and can engage cloth A part for the tether in tether path is put, so as to which tether is fixed into tether attachment members.

In certain embodiments, a kind of device includes tether attachment members, and the tether attachment members include base component And lever arm, the lever arm are connected to base component with can moving.Base component and lever arm together define tether and led to Road, the part that can be received from the tether of artificial heart valve extension via the tether path pass therethrough.Base component Stop pin passage is defined, the stop pin passage intersects and is in fluid communication with it with tether path, and stop pin is arranged In stop pin passage.Lever arm construction is into from first position and second place motion, in the first position, tether A part is inserted into tether path, and in the second place, stop pin fixes the tether being arranged in tether path To tether attachment members.

In certain embodiments, a kind of device includes tether attachment members, and the tether attachment members include base component And bushing, the bushing can be rotationally coupled to base component.Base component and bushing each define tether path at least A part, the part that can be received from the tether of artificial heart valve extension via the tether path pass therethrough.Base portion Component defines stop pin passage, and the stop pin passage intersects and is in fluid communication with it with tether path, and stop pin It is at least partially disposed in stop pin passage.Bushing defines cam channel, and the drive portion of stop pin is received in described In cam channel.Bushing is configured to rotate relative to base component, so as to which cam channel makes stop pin in stop pin passage Interior linear motion, so that stop pin moves from first position and the second place, in the first position, stop pin and tether path Spaced a distance, in the second place, stop pin, which intersects and engaged with tether path, to be arranged in tether path A part for tether, so as to which tether is fixed into tether attachment members.

In certain embodiments, a kind of method include by a part for the tether extended from artificial heart valve be inserted into by In the tether path that tether attachment members limit.Tether attachment members are arranged to adjoin the opening in the ventricle wall of heart, tether From the opening extension.Tether attachment members are activated, to be arranged in the stop pin passage limited by tether attachment members Stop pin intersect with tether path and engage a part for the tether being arranged in tether path, so as to which tether is fixed to Tether attachment members.

When in this manual in use, unless otherwise indicated by context, otherwise " one " of singulative, "one" and It is " described " to include a plurality of referents.Thus, for example, term " component " is intended to indicate that single component or multiple components Combination, " a kind of material " be intended to indicate that one or more materials or its combination.

When used herein, what word " nearside " and " distal side " referred to be proximate to respectively and the operation away from such as medical treatment device The direction of person.Thus, for example, medical treatment device near patient body (for example, contacting patient body or being arranged in patient body It is interior) end refer to the distal end of medical treatment device, and relative with distal end and near such as medical treatment device user (or makes The hand of user) end refer to the near-end of medical treatment device.

In certain embodiments, external membrane of heart mattress system described herein can be used in anchoring compressible artificial heart valve Replacement Part (for example, artificial mitral valves), can use and be arranged into through catheter delivery system in the beating heart of closing.Can The operation for for example carrying out valve guiding using space under Intercostal Space or xiphoid-process via such as Minimally Invasive Surgery is such to arrange Adjustable tether and external membrane of heart mattress system.In such operation, artificial valve can be formed as being compressed to fill Fit in induction system, and can be from induction system by the secondary valve for being drained into target site such as bicuspid valve or tricuspid valve In ring.

Compressible artificial mitral valves can have such shape, for example, the shape is characterised as including valve The tubular stent body of leaf and atrium cuff.This allows valve to be seated in mitral annulus and protected by primary mitral leaflet Hold.It can be provided using the use of the flexible valve of apex tether attachment and comply with the motion of heart and complying with for geometry Property.The geometry of heart and motion are notoriously thickened with successive twist motion by cardiac muscle to show the double of complexity Stage left ventricle deforms.The extra ventricle tether fixed using apex helps to maintain the annulus position of artificial valve and not Allow valve to move, while substantially reduce the tension force between cuff and myocardium girder, and preferably eliminate the leakage of valve week.Make It can aid in and blood coagulation and blood flow is reduced or eliminated with compliance heart valve prosthesis and specific shape and feature structure Mechanics problem, including left ventricular outflow tract (LVOT) interference problem.A variety of known valves are unable to solve blood stream The problem of dynamic and sustainer/aortic valve mould contracting.

In structure, artificial heart valve can include：Self-expansion type tubular frame, the self-expansion type tubular frame exist One end (atrium end) place has cuff；One be preferably located near the ventricle end or ventricle end of valve Or multiple attachment points, one or more tether can be attached to one or more of attachment points；With leaflet component, the leaflet Component includes leaflet, and the leaflet can be formed by stable tissue or other appropriate biomaterials or synthetic material. In one embodiment, leaflet component can include wire forming part, wherein, the wire rod structure of shaping combines stable tissue together Use, to establish leaflet supporting construction, the leaflet supporting construction can have 1,2,3 or 4 leaflet or arrangement Valve cusps wherein.In another embodiment, leaflet component can be no wire rod and stable group is only used only Knit with rack body to provide leaflet supporting construction, and the leaflet supporting construction there can be 1,2,3 or 4 valve Leaf or the valve cusps being arranged therein.

Upper ferrule portion can be by thermoforming tubulose Nitinol structure (such as by weave yarn or laser cut tube Formed) a part and formed so that lower part keep tubulose, and upper part from tubular portion open and expand with formed increase Wide sleeve structure, described sleeve pipe structure are capable of being shaped to regular or the irregular chimney-like or cannula-like of various functions Shape.

As described herein, artificial mitral valves can be via being connected to one or more tether of anchor in heart exterior Opening position anchor to heart.For example, tether can be connected to artificial mitral valves and be extended heart, and utilize anchoring dress Put and be fixed on external position (such as epicardial surface), as described herein.In other surgery situations, anchor as described herein It is fixedly mounted with and puts and can be used together with one or more such tether, in other surgery situations, can requires so Tether from tube cavity extend to outside anchoring position.

Fig. 1 is the left ventricular LV of heart and atrium sinistrum LA sectional view, and heart has the transcatheter people being arranged therein Bicuspid valve PMV and external membrane of heart anchor EAD as described herein are made, the external membrane of heart device EAD consolidates artificial mitral valves PMV It is fixed in place.Fig. 1 illustrates artificial mitral valves PMV, and the artificial mitral valves PMV is seated in native valve ring and utilized artificial Bicuspid valve PMV atrium cuff AC, the radial tension from primary leaflet and ventricle tether T is kept here, the ventricle system Rope T is fixed to artificial mitral valves PMV and external membrane of heart anchoring piece EAD using attachment part Tp.With reference to specific embodiment below more Add the different embodiments for describing external membrane of heart anchor in detail.

Fig. 2 is (to be also referred to as " anchor " herein according to the schematic diagram of the external membrane of heart anchor 100 of an embodiment Or " external membrane of heart anchoring piece ").Anchor 100 can be used in anchoring or fixed and arranged in the atrium sinistrum of heart and left ventricle Between artificial mitral valves PMV.Anchor 100 for example can be used in via such as reference picture 1 in above-described suture tether 128 anchorings or fixed artificial mitral valves PMV.Anchor 100 can also seal formation during artificial mitral valves PMV is implanted into and exist The perforation of the ventricle wall (not shown in Fig. 2) of heart.Anchor 100 can also be applied in other purposes, to anchor doctor Treat the such opening of device (such as any artificial atrioventricular valve or other cardiac valves) and/or sealing such as perforation.

Anchor 100 can include pad (or pad assembly) 120, tether attachment members 124 and stop pin 126.One In a little embodiments, anchor 100 can include reference picture 3 to the sleeve gasket described in Fig. 6 (not shown in Fig. 2).Pad 120 can connect Touch the epicardial surface of heart and can be made up of the surgical material of any appropriate bio-compatible.Pad 120 can be used in The surgical punch that auxiliary seal is formed when being implanted into artificial mitral valves.In certain embodiments, pad 120 can include slit, institute State the edge that slit extends radially into pad 120 so that pad 120 can by make pad 120 via slit slide on tether 128 and It is attached to or is arranged in around tether 128.Reference picture 9 and Figure 10 following describes such embodiment.

In certain embodiments, pad 120 can be made up of two-sided down material, to promote to pad 120 ingrowings to puncture In area.For example, pad or felt gauze can be made up of felted polyester and can be cut into any appropriate size Or shape, such as Bard product PTFE Felt Pledgets, its nominal thickness is 2.87mm.In certain embodiments, The diameter of pad 120 can be more than the diameter of tether attachment members 124.Pad 120 can have circular either dish type or other suitable When shape.

Tether attachment members 124 can provide anchoring and mounting platform, and one or more tether 128 can be connected to described Anchoring and mounting platform (for example, fasten or coupled with pin).Tether attachment members 124 can include：Base component (does not show Go out), the base component at least defines a part of (not shown) of tether path, and tether 128 can be led to by the tether Road is received and passes through tether attachment members 124；With stop pin passage (not shown), can be connect by the stop pin passage Receive stop pin 126.As being described more fully below with reference to specific embodiment, stop pin passage can lead to tether Road is in fluid communication, during so that proper stop pin 126 is arranged in stop pin passage, the stop pin when stop pin passes through tether path 126 can contact or pierce through tether 128.

Stop pin 126 can be used in being tightened against in ventricle wall in anchor 100 and tether 128 It is drawn as being held in place tether 128 after desired tensioning state.For example, tether 128 can be extended through in pad 120 Hole, through sleeve gasket (if anchor include sleeve gasket if) in hole and the tether path through tether attachment members 124. When tether 128 extends through the tether path of tether attachment members 124, stop pin 126 be inserted into stop pin passage or Person moves in stop pin passage, so that it pierces through or otherwise engaged tether 128.Therefore, stop pin 126 can be with Tether 128 is intersecting and tether 128 is fixed into tether attachment members 124.

Tether attachment members 124 can be formed by various appropriate bio-compatible materials.For example, in some embodiments In, tether attachment members 124 can be made up of polypropylene or other hard or the polymer of semi-rigid, and can be by polyester Velvet covers, to promote ingrowing.In other embodiments, tether attachment members 124 can be for example by metal (such as NiTi Promise) or ceramic material be made.Tether attachment members 124 can be of different sizes and/or shape.For example, tether is attached Component 124 can be substantially plate-like.

In certain embodiments, tether attachment members 124 can include lever arm (not shown in Fig. 2), the lever arm It can between the open and the closed positions move, tether 128 is loaded in tether attachment members 124 in the open position It is interior, tether 128 is fixed to tether attachment members 124 in the closing position.For example, in certain embodiments, work as lever arm When moving to closing position, tether path and stop pin passage are into overlapping relation so that the engagement of stop pin 126 is arranged in tether and led to Tether 128 in road.In certain embodiments, when lever arm is in an open position, instrument can be used to lock stop pin Moved in rationed marketing passage, to cause stop pin engagement to be arranged in the tether 128 in tether path.In this embodiment, locking Rationed marketing 126 is fixed after tether 128, and lever arm can move to closing position.

In certain embodiments, tether attachment members 124 can include bushing, and it is attached that the bushing is movably coupled to tether The base component of connection member 124.Bushing can limit passage, and the passage can receive stop pin (or stop pin assembly) 126 part so that when bushing rotates, bushing is used as cam to cause the straight line in stop pin passage of stop pin 126 to transport It is dynamic.Just as in the previous embodiment, when stop pin 126 moves in stop pin passage, stop pin can engage or pierce through cloth Put the tether 128 in tether path and tether 128 is fixed to tether attachment members 124.Herein by reference to Figure 22 to Figure 31 Describe such embodiment.

In use, after PMV is had been placed in heart, it is inserted into from the tether of PMV extensions to anchor And can be by the tension adjustment on tether attachment arrangement to desired tension force in 100 tether path.Alternatively, at some In situation, before PMV is placed in heart, you can the tether extended from PMV is connected into anchor 100.It can cause Dynamic anchor 100 (is, for example, some parts or the lever arm of the anchor of tether attachment members 124 according to specific embodiment Or bushing) so that stop pin 126 intersects with tether path and engages the part being arranged in tether path of tether, so as to Tether is fixed to tether attachment members.In certain embodiments, before tether is inserted into tether path, can activate Anchor 100, to be configured to anchor 100 to receive tether.For example, if tether attachment members are included movably Ground is connected to the lever arm of base component, then lever arm may be needed to move to open position to allow to insert tether.At some In embodiment, it can be made by activating anchor 100 relative to the base component rotary liner of tether attachment members 124 Stop pin 126 is obtained to move from first position and the second place, in the first position, stop pin is opened with tether channel spacing, The second place, stop pin intersect with tether path and engage or pierce through a part for tether.

One embodiment of external membrane of heart anchor 100 is shown into Fig. 6 in Fig. 3.External membrane of heart anchor 100 ( This is also referred to " anchor " or " external membrane of heart anchoring piece ") flexible pad 220, sleeve gasket 222, tether attachment members can be included 224 and stop pin 226 (being shown in Fig. 4).Anchor 200 can be used in via the suture tether 228 shown in Fig. 5 and Fig. 6 Anchoring or fixed artificial mitral valves (Fig. 3 is to not shown in Fig. 6).Anchor 200 can also be sealed in artificial two point of implantation The perforation 230 in the ventricle wall V (referring to Fig. 5 and Fig. 6) of heart is formed during valve.

Flexible pad 220 (being also referred to herein " pad ") can contact the epicardial surface of heart and can be by any appropriate Bio-compatible surgical material is formed.Pad 220 can be used in the surgical punch that auxiliary seal is formed when being implanted into artificial mitral valves (for example, perforation 230).Pad 220 can be made up of the material same or similar with pad 120, and can have not Same size and dimension.Pad 220 is shown as the shape with circular or plate-like, it should be understood that be alternatively to make With other appropriate shapes.Pad 220 defines hole 225 (referring to Fig. 4), can by the hole 225 receive tether 228 (Fig. 5 and Shown in Fig. 6), as being described more fully below.

Sleeve gasket 222 can be arranged between pad 220 and tether attachment members 224 and can be used in sealing and may pad The gap occurred between 220 and tether attachment members 224 or leakage.Sleeve gasket 222 can be for example fabricated from a flexible material, so that Obtaining it can be compressed when tether attachment members 224 and/or pad 220 for example fasten against site of puncture against ventricle wall.Set Pad 222 can be connected to the separate part of pad 220 and tether attachment members 224 or can be attached with pad 220 and/or tether Component 224 integratedly or integrally is formed.Sleeve gasket 222 can be used in preventing to flow along the path of suture tether 228 Dynamic haemodynamics leakage.Sleeve gasket 222 can also limit hole (not shown), can receive tether 228 by the hole.

Tether attachment members 224 can provide anchoring and mounting platform, one or more tether 228 (referring to Fig. 5 and Fig. 6) (such as fastening) can be coupled and arrive the anchoring and mounting platform.Tether attachment members 224 include：Base component 240, the base Portion's component defines axial tether path 235, and tether 228 can be received and passed through by the axial tether path 235 Tether attachment members 224；With stop pin passage 234, stop pin 126 can be received by the stop pin passage 234.As under As text is described in more detail, stop pin passage 234 can be in fluid communication with tether path 235, so that proper stop pin 226 When being arranged in stop pin passage 234, as stop pin 226 passes through tether path, stop pin 226 can contact tether 228.Lock Rationed marketing 226 can be used in after anchor 200 fastens against ventricle wall V tether 228 being held in place.For example, it is Rope 228 can extend through hole 225 in pad 220, through the hole (not shown) in sleeve gasket 222 and pass through tether attachment members 224 tether path 235.When tether 228 extends through the tether path 235 of tether attachment members 224, the energy of stop pin 226 Stop pin passage 234 is enough inserted through, so that it pierces through tether 228.Therefore, stop pin 226 can laterally intersect with tether 228 And tether 228 is fixed to tether attachment members 224.

Tether attachment members 224 can be made up of any appropriate bio-compatible material.For example, in some embodiments In, tether attachment members 224 can be made up of polypropylene or other hard or the polymer of semi-rigid, and can be by polyester Velvet covers, to promote ingrowing.In other embodiments, tether attachment members 224 can be for example by metal (such as NiTi Promise) or ceramic material be made.Tether attachment members 224 can be of different sizes and/or shape.For example, tether is attached Component 224 can be substantially plate-like.

In certain embodiments, tether attachment members 224 can be substantially plate-like and diameter between such as 1.0cm extremely Between 3.0cm.In other embodiments, tether attachment members 224 can have for example between 0.2cm to straight between 5.0cm Footpath.For example, the tether attachment members 224 of large-size can be desirably applied to such as hernia repairing, stomach and intestine repairing.

Plate-like tether attachment members 224 for capturing and anchoring suture can also use, and it is to anchoring position Very little is damaged caused by tissue or is not damaged, this is with piercing the suture anchoring piece in tissue using screw or barb not Together.Suture is used in addition, substituting, plate-like tether attachment members 224 can slide on tether 228 easily and rapidly, This can realize effective closed permanent of large perforation.It may be taken by suture surgically closing large perforation and difficult.When During perforation in closed-heart, it is desirable to surgeon suture perforation increased difficulty may increase jeopardize patient vitals' and Send out the probability of disease.This is particularly true in the case of use does not convey and arrange artificial heart valve with not opening chest through microcatheter technology. It is probably undesirable to suture perforation of ventricle in this case.

Fig. 5 and Fig. 6 illustrates the site of puncture in the left ventricular wall V for extending through heart and is connected to anchor 200 Tether 228.Fig. 5 is illustrated in the epicardial surface against ventricle wall V and by the anchor 200 before fastening, and place Sleeve gasket 222 in uncompressed state or construction.Tether 228 can be alternatively on tether attachment members 224, to enter One step improves anchoring.

Fig. 6 illustrates the anchor 200 fastened against ventricle wall V unfaithful intention film surface.As shown in fig. 6, anchoring dress Site of puncture can be compressed against and contact epicardial surface by putting 200.Tether attachment can be already affixed in tether 228 The end portion of tether 228 is cut after component 224 or after anchor 200 has been seated against on epicardial surface Divide 232 (being shown in Fig. 5).

Fig. 7 illustrates external membrane of heart anchor 300 (being also referred to as herein " anchor " or " external membrane of heart anchoring piece ") Embodiment, the external membrane of heart anchor 300 is similar with anchor 200, and difference is that anchor 300 does not include sleeve gasket (such as above-mentioned sleeve gasket 222).Anchor 300 can include flexible pad 320, tether attachment members 324 and stop pin 326, institute State flexible pad 320, tether attachment members 324 and stop pin 326 can be respectively configured to it is attached with above-mentioned flexible pad 220, tether Connection member 224 and stop pin 226 are same or similar.Anchor 300 can with anchor 200 it is same or similar be used for pass through Artificial mitral valves' (not shown) is fixed by suture tether (not shown).Such as when need not be prevented with leakproof sleeve pipe along suture During the haemodynamics leakage of the path flowing of tether, it may be necessary to use anchor 300.

Fig. 8 illustrates external membrane of heart anchor 400 (being also referred to as herein " anchor " or " external membrane of heart anchoring piece ") Embodiment, the external membrane of heart anchor 400 is similar with anchor 200 and anchor 300, and difference is anchor 400 do not include pad (for example, pad 220 and 320).Anchor 400 can include tether attachment members 424, sleeve gasket 422 and locking Pin 426, the tether attachment members 424, sleeve gasket 422 and stop pin 426 can be configured to be attached structure with above-mentioned tether Part 224, sleeve gasket 222 and stop pin 226 are same or similar.Anchor 400 can with for described in above-described embodiment Same or similar mode is anchored via tether (not shown) or fixed artificial mitral valves' (not shown).Such as when need not During flexible pad, for example when rope moves to new position, it may be necessary to use anchor 400.In this case, ventricle Perforate smaller (for example, minor diameter) and can need not control blood flow with pad.

Fig. 9 and Figure 10 illustrates the embodiment of pad 520, and the pad 520 can be included in the external membrane of heart as described herein In anchor.Pad 520 defines axial hole 525 and the slit 537 connected with hole 525.Slit 537 extends radially to pad 520 outward flange so that pad 520 can be arranged in around tether 528 or can be removed from tether 528 pad 520 (referring to figure 10) and length slide downward of the pad 520 along tether 528 need not be made.For example, can be by making pad 520 lateral from sidepiece Slide and pad 520 is arranged in around tether 528, to cause tether to be inserted into slit 537 and be positioned at the opening of pad 520 In 525.Pad 520 can utilize and be fixed to tether such as pin, fixture.

In order to remove pad 520, pad 520 can similarly slide off sidepiece for example slide into heart ventricle top it Outside.Thereby, it is possible to remove pad 520, and whole anchor need not be removed.Pad 520 can by with for preceding embodiment (such as pad 220,320,420) is formed in the same or similar material of above-described material, and can be as described above For closing (for example, in ventricle wall) site of puncture.

Pad 520 can also be realized uses guide sheath at the apex of the heart, and the guide sheath can limit amount of exercise simultaneously And pass through the apex of the heart.For example, when retracting sheath, the pad 520 for having slit can slip into from side, so as to allow to remove the sheath phase Between control tether tension force.Also the pad 520 with slit 537 can be used independently of sheath as described above.

Figure 11 and Figure 12 illustrates the tether attachment members 624 that can be included in anchor as described herein Embodiment.The each feature described herein for tether attachment members 624 can be also included in herein for other embodiments In tether attachment members described in (for example, 124,224,324,424).As described above, stop pin 626 (Figure 11 is shown) can be used In tether/suture is fixed into tether attachment members 624 in a manner of preceding embodiment as described above is similar.

Tether attachment members 624 show that position has plate-like and can include base component 640, the base component 640 Winding passages 632, axial tether path 635, radial passage 633 and stop pin passage 634 are defined, the locking can be passed through Sell passage 634 and receive stop pin 626.Base component 640 also defines proximal open 615 and distal openings 617, and the nearside is opened Mouth 615 and the distal openings 617 connect with tether path 635.Base component 640 can include being located at proximal open 615 The Chamfer Edge at place either introducing portion 627 and it is distally located opening 617 at Chamfer Edge or introducing portion 629, with Allow suture (for example, tether) is readily incorporated into tether path 635 to and reduced the resistance seam of tether attachment members 624 The lateral cutting force of zygonema.Radial passage 633 can allow for user rapidly to capture and dispose the tether for being ready for anchoring (not shown).Winding passages 632 can allow for user rapidly by tether on tether attachment members 624.Use volume Can allow for user rapidly to anchor tether around passage 632 and radial passage 633, at the same allow user untie and again compared with Quasi- anchor, so as to the tension force for special-purpose adjustment effect as needed on tether (not shown).

Figure 13 to Figure 16 illustrates a part for another embodiment of external membrane of heart anchor 700.External membrane of heart anchoring dress Putting 700 includes tether attachment members 724 and flexible pad or component of the fabric (Figure 13 is to not shown in Figure 16).Tether attachment members 724 include：Base component 740, the base component 740 define stop pin passage 734, and the stop pin passage 734 can By with stop pin 726 is received wherein in a manner of manner described above is similar for preceding embodiment；With circumference Pad passage 742.Pad passage 742 can be used in the flexible pad of external membrane of heart anchor 700 or component of the fabric (Figure 13 to Figure 16 Not shown in) it is fixed to tether attachment members 724.For example, flexible pad can be arranged in the distal portions of tether attachment members 724 On, so that proper anchor 700 is as preceding embodiment, when being fixed to ventricle wall as discussed above, flexible pad connects Touch ventricle wall.

Tether attachment members 724 also define：Tether path 735, (the ginseng of tether 728 can be received by tether path 735 See, such as Figure 15 and Figure 16)；And the proximal open 715 and distal openings 717 connected with tether path 735.Opened in distal side Include Chamfer Edge or introducing portion 729 at mouthfuls 717 or near distal openings 717, with allow tether 728 (see, for example, Figure 15 and 16) easily penetrate into tether path 735 and reduce tether attachment members 724 against the side cut of tether 728 Cut power.

Lever arm 738 is connected to base component 740, and the lever arm 738 together defines tether with base component 740 and led to Road 735.Lever arm 738 can move between the first position and the second position, as illustrated in fig. 16 in first position, lever arm 738 are biased into lower position by spring member 739, are in extension bit in the second place, lever arm 738 as shown in FIG. 13 to 15 Put, to allow tether 728 being placed in tether path 735.For example, lever arm 738 can be along the arrow A shown in Figure 15 Direction rotates, so that lever arm 738 moves to its second place or extended position.In some cases, suture or rope energy It is enough in the second place that lever arm 738 is pulled to extension.

When being shown in first position, for example, in figures 14 and 15, the end of stop pin 726 be arranged to Lever arm 738 and tether path 735 are spaced apart a certain distance.When stop pin 726 is spaced apart with tether path 735, tether 728 can be inserted into tether path 735 as shown in figure 15.Then, tether 728 can be tensed to tension force it is expected, be then able to Trip lever arm returns to first position so that it is biased, as shown in figure 16.Arrived when lever arm 738 moves (for example, being biased) During first position, wherein tether 728 extends through tether path 735, stop pin 726 pierce through tether 728 or with the phase of tether 728 Hand over, and the end of stop pin is then disposed in the chamber 736 limited by lever arm 738, is so as to which tether 728 be fixed to Rope attachment members 724.

Figure 17 to Figure 21 illustrates a part for another embodiment of external membrane of heart anchor 800, the external membrane of heart anchor Be fixedly mounted with and put 800 and include tether attachment members 824 and flexible pad or component of the fabric (not shown in Figure 17 to 21).Tether is attached structure Part 824 includes base component 840 and lever arm 838, and the lever arm 838 is pivotally coupled to base component 840.Base component 840 define circumferential pad passage 842, and in the circumferential pad passage 842, flexible pad can be connected to tether attachment members 824. For example, flexible pad can be arranged on the distal portions of tether attachment members 824 so that when anchor 800 is as previous Embodiment when being fixed to ventricle wall as discussed above, flexible pad contact ventricle wall.

Lever arm 838 and base component 840 together define tether path 835, can be connect by the tether path 835 Tether 828 is received, as shown in figure 17.Base component 840 also defines the distal openings 817 being in fluid communication with tether path 835 With another opening.Tether 828 is inserted into by distal openings 817 (near the side to be implanted of ventricle wall) and extended logical The part limited by base component 840 of tether path 835 and the part limited by lever arm 838 of tether path 835 are crossed, so Left afterwards from another opening.As preceding embodiment, base component 840 is at the distal openings 817 of tether path 835 Including Chamfer Edge or introducing portion 829, to allow tether 828 is readily incorporated into tether path 835 and reduced Lateral cutting force of the tether attachment members 824 against tether 828.

Lever arm 838 defines stop pin passage 844, and stop pin 826 can be movably arranged in the stop pin passage In 844.Stop pin 826 includes drive portion 846 and piercing portions 849.As shown in Figure 17 and Figure 18, stop pin passage 844 wraps The part with variable-diameter is included, the drive portion 846 of stop pin 826 can be movably arranged in the part.For example, rise Subdivision 846 can be threadedly coupled to the inwall of stop pin passage 844 so that stop pin 826 can be in first position and second Moved between putting, be arranged in the part 839 of stop pin passage 844 in first position drive portion 846 as illustrated in fig. 17 Interior and piercing portions 849 are spaced apart with tether path 835, and being arranged in stop pin in the second place drive portion 846 leads to In the part 845 (Figure 17 and Figure 18 shown in) in road 844, and piercing portions 849 extend through tether path 835, so as to Tether 828 is pierced through in engagement.As described in detail below, lever arm 838 also defines opening 847, the opening 847 and locking Pin passage 844 connects and can receive driving instrument, and the driving instrument can be used in making stop pin 826 in stop pin passage Moved in 844.

Lever arm 838 can be in the first position shown in such as Figure 17 and Figure 18 or open position and as shown in figure 21 Moved between the second place or closing position, in the first position or open position, lever arm 838 is from the edge of base component 840 Proximal direction extension, in the second place or closing position, proximal face 819 and the base component 840 of lever arm 838 Proximal face 821 is substantially flush.When lever arm 838 is in first position or open position, means of delivery 848 can be connected to Lever arm 838, as illustrated in figures 19 and 20.The bottle opener 849 that means of delivery 848 can include showing in Figure 18 is (for example, screw Knife), the bottle opener 849 can engage the drive portion 846 of stop pin 826, so that stop pin 826 is in stop pin passage 844 Motion.

In operation, tether 828 is inserted into tether path 835 and extended out and position from another opening In in means of delivery 848.It is then able to tense tether 828 to expectation tension force.In the situation that tether 828 is under it is expected tension force In, the bottle opener 849 of means of delivery 848 is then able to make stop pin 826 move to second from first position as shown in figure 17 Put, in the second place, piercing portions 849 pierce through or engaged tether 828, so as to which tether 828 be attached fixed to tether Component 824.For example, the bottle opener 849 of means of delivery 848 can make stop pin 826 torsionally move to second from first position Put.After tether 828 is fixed to tether attachment members 824, means of delivery 849 can be removed and lever arm 838 can be transported Move to second closure or closing position, as shown in figure 21.

Figure 22 to Figure 30 illustrates the external membrane of heart anchor according to another embodiment.External membrane of heart anchor 900 wraps Include tether attachment members 924, pad assembly 920, pipe component 955 and lid component 956.Tether attachment members 924 include base portion structure Part 940, bushing 950, retaining ring 952, stop pin assembly 926 and pin component 953.Stop pin assembly 926 includes drive portion 946 With piercing portions 949.Base component 940 defines circumferential pad passage 942, keeps passage 951 and stop pin passage 934.Pad is logical Road 942 can be used in pad assembly 920 being connected to tether attachment members 924.Passage 951 is kept to receive retaining ring 952 Outward flange, the retaining ring 952 are used to bushing 950 remaining to base component 940.Base component 940 also define otch or Person's ratchet 943, for example, as shown in Figure 23,25 and 30.

Pipe component 955 is connected to base component 940 and base component 940, bushing 950 and pipe component 955 limits together Tether path 935, the tether path 935 can be passed through and receive tether (not shown).The lid component 956 can be by such as fabric Material such as Dacron is formed.Tether passage 935 intersects and in flow communication with stop pin passage 934.

Pad assembly 920 includes top pad part 958, bottom pad part 959 and the filler component 957 being disposed there between.Top Portion's pad part 958 and bottom pad part 959 can be formed by such as flexible fabric material.Top pad part 958 and bottom pad Part 959 can limit central opening, and pipe component 955 can pass through the central opening.A part for top pad part 958 It is received in the passage 942 of base component 940, as shown in Figure 25 to 27.

The outer peripheral portion of bushing 950, which is received in, to be kept in passage 951 so that bushing 950 can be relative to base component 940 rotations, to activate stop pin assembly 926 as described in more detail below.As illustrated, for example, in Figure 28 In Figure 29, bushing 950 includes the arm 961 with convex portion 962.Convex portion 962 can be received in the otch of base component 940 In 943 and it is used as retainer or limited part, to limit the rotation of bushing 950.The slit 963 limited by bushing 950 makes arm 961 It can bend and allow convex portion 962 to move or move from otch 943 in otch 943.As illustrated, for example in Figure 27 and In Figure 29, bushing 950 defines bending channel 960 on the base section of bushing 950.Bending channel 960 for it is asymmetric (or Spirally) and receive the drive portion 946 of stop pin assembly 926.When bushing 950 rotates relative to bottom member 940, lining Set 950 is used as cam so that stop pin assembly 926 moves along a straight line in stop pin passage 934.Stop pin assembly 926 can be from One position moves to the second place, and in the first position, piercing portions 949 are arranged in tether path as illustrated in figs. 25 and 26 Outside 935, in the second place, piercing portions 949 extend through tether path 935 as shown in figure 27.(the ginseng of pin component 953 See such as Figure 26) can be formed by metal material, the metal material than anchor other part radiopacities more It is strong and therefore visual for the user (such as doctor) using traditional imaging modality, allow the user to determine Stop pin assembly 926 has been fully moved to the second place.

In use, when stop pin assembly 926 is in first position, such as artificial mitral valves is connected to and are extended logical The tether (not shown) for the site of puncture crossed in the ventricle wall of heart is inserted into by tether path 935.950 subsequent energy of bushing 180 degree is enough rotated, so that stop pin 926 moves along a straight line in stop pin passage 934 so that piercing portions 949, which extend through, is Tether is pierced through in rope path 935 and engagement, so as to which tether is fixed into tether attachment members 924.For example, at stop pin When first position, the convex portion 962 of bushing 950 is arranged in one of otch 943 of base component 940 (that is, at the first convex portion In the first otch, the second convex portion is in the second otch).Then bushing 950 can rotate 180 degree so that move convex portion 962 The otch 943 of base component 940 is left, and at the end of 180 degree rotates, convex portion 962 moves to the another of base component 940 In individual otch 943 (that is, the first convex portion is now arranged in the second otch, and the second convex portion is now arranged in the first otch).

Base component 940 can also include otch section 966 and limit side opening 967 (see, for example, Figure 22 and Figure 23), The side opening 967 can be used in conveying device being connected to external membrane of heart anchor 900.For example, Figure 31 illustrates conveying dress 948 are put, the conveying device 948 has link arm 968 and attachment pegs (not shown), and the attachment pegs extend internally from arm 968. Side opening 967 can receive attachment pegs and otch section 966 can be engaged by link arm 968.

Although having had been described above a variety of embodiments, but it is to be understood that they are only exemplary rather than Restricted.In the case where the above method points out that particular event occurs in a specific order, the order of particular event can be changed. In addition, particular event can be performed simultaneously in parallel processing when feasible, and one after the other perform particular event as described above.

Represented in above-mentioned schematic diagram and/or embodiment according to specific direction or position the situation of specific embodiment arranged In, the arrangement of part can be changed.Although it has been particularly shown and has described embodiment, but it is to be understood that can By in the form of and details various changes can be made.Any part of device described herein and/or method can be with arbitrary group Conjunction mode is combined, except mutually exclusive combination.Embodiment described herein can include described different embodiments Function, part and/or the various combinations of feature structure and/or sub-portfolio.

Claims

1. a kind of device for being used to anchor artificial heart valve, including：

Tether attachment members, the tether attachment members include base component and bushing, and the bushing can be rotationally coupled to The base component, the base component and bushing each define at least a portion of tether path, via the tether path The part that can be received from the tether of artificial heart valve extension passes therethrough, and the base component defines that stop pin leads to Road, the stop pin passage intersect and are in fluid communication with it with the tether path；With

Stop pin, the stop pin are at least partially disposed in the stop pin passage, and bushing defines cam channel, described The drive portion of stop pin is received in the cam channel,

Bushing is configured to rotate relative to the base component, so as to which the cam channel makes the stop pin in the lock Moved along a straight line in rationed marketing passage, so that the stop pin moves from first position and the second place, it is described in the first position Stop pin is opened with the tether channel spacing, and in the second place, the stop pin intersects and connect with the tether path A part for the tether being arranged in tether path is closed, so as to which tether is fixed into the tether attachment members.

2. device according to claim 1, in addition to：

Pad, the pad are connected to the tether attachment members, and the pad is configured to contact ventricle wall, to cause the shield Put between ventricle wall and the tether attachment members.

3. device according to claim 1, in addition to：

Pipe component, the pipe component are connected to the base component, and the pipe component defines a part for the tether path.

4. device according to claim 1, in addition to：

Pipe component, the pipe component are connected to the base component, and the pipe component defines a part for the tether path； With

The lid component, the The lid component are arranged on the pipe component.

5. device according to claim 1, wherein, the base component defines ratchet, and the ratchet is configured to The convex portion on the bushing is received wherein, to limit rotation of the bushing relative to the base component.

6. device according to claim 1, wherein, the cam channel is asymmetrical.

7. device according to claim 2, wherein, the pad includes top pad part, bottom pad part and is arranged in Filler component between the top pad part and the bottom pad part.

8. device according to claim 7, wherein, the top pad part and the bottom pad part can be by flexibilities Textile material is formed.

9. device according to claim 1, wherein, the base component limits a pair of notches section and a pair of side openings, The pair of side opening is defined in the side wall of the base component near the pair of otch section,

The pair of side opening and the pair of otch section can be engaged by a pair of link arms with attachment pegs of conveying device, The attachment pegs can be received in the pair of side opening.

10. device according to claim 1, wherein, when the stop pin is in the stop pin and the tether path During the intersecting second place, the stop pin pierces through a part for the tether being arranged in the tether path and by institute State tether and be fixed to the tether attachment members.